The first phase in pharmaceutical research and development is the initial discovery of new chemical entities.
Companies must decide which compounds to take forward, assessing the medical need and feasibility of each.
Scientists are using computerized chemical databases, molecular modeling graphics, and automatic gene sequencing machines to rapidly select and adapt compounds for development.
Economic units assess the cost and quality of life benefit of potential new drugs as early as possible.
The second phase is clinical trials.
These typically involve three phases, an average of 200 patients per trial, and are the longest, most costly stages in new drug development.
This process must be conducted internationally, because US, Japanese and European authorities often require different clinical trials.
Considerable data assembled from trials is subjected to detailed statistical evaluation and medical interpretation.
Doctors and their patients are becoming more reluctant to take part, so companies must spend more time and money to recruit hundreds or thousands of people required.
Computers are used to keep track of the immense volumes of patient data amassed, to obviate mountains of paperwork, and to cut approval times.
The final phase, the regulatory and licensing process, has become increasingly complex and demanding.
Drugs must go through these processes in individual countries at the same time.
Currently, the development period for new drugs, from discovery to marketing, lasts about 12 years.
Companies are working to shorten that period to an average of eight to nine years in the US and Europe, and 12 years in Japan.
